2-chloro-3-(2-chloroethyl)-1,3,2-oxazaphosphinane 2-oxide

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1991

Report date:

1992

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

no

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

81485-04-3

EC Number:

617-238-1

Cas Number:

81485-04-3

IUPAC Name:

81485-04-3

Constituent 2

Reference substance name:

2-Chloro-3-(2-chloro-ethyl)-[1,3,2]oxazaphosphinane 2-oxide

IUPAC Name:

2-Chloro-3-(2-chloro-ethyl)-[1,3,2]oxazaphosphinane 2-oxide

Details on test material:

Batch 11094 4th Dec 1990
Purity > 99%

Test animals / tissue source

Species:

rabbit

Strain:

other: White Russian (Albino)

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Asta Medica
- Age at study initiation: 7-9 months
- Weight at study initiation: 2.3 - 2.43 kg
- Diet): approx 120 g/day standard diet
- Water: ad libitum
- Acclimation period: 1 day


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21-24
- Humidity (%): 40-70

- Photoperiod 12 hrs dark / 12 hrs light:

Test system

Vehicle:

unchanged (no vehicle)

Controls:

not required

Amount / concentration applied:

0.063 to 0.073 g (volume 0.1 ml)

Duration of treatment / exposure:

Duration of the obserrvation period - 4, 7 or 10 days after aplication

Observation period (in vivo):

Observations times 1, 24, 48 ,72 hours

Number of animals or in vitro replicates:

3

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

overall irritation score

Basis:

mean

Time point:

other: 72 hours

Score:

2.1

Results 2

Irritation parameter:

iris score

Basis:

mean

Time point:

other: 72 hours

Score:

2.1

Results 3

Basis:

mean

Time point:

other: 72 hours

Score:

9.7

Results 4

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

other: 72 hours

Score:

14.6

Any other information on results incl. tables

Observed eye lesions

Cornea                         Diffuse opacity, details of iris still visible, easily discernible translucent areas with details of iris slightly obscured.

Iris                                 Moderate partial hyperemia, moderate circumcorneal hyperemia.

Conjunctiva                Hyperemia, diffuse beefy redness of all sections, slight or obvious swelling with partial eversion of lids and with lids about halfclosed, eye filled with a white mucus, edge of the eye lids reddened and partially incrustrated

Additional lesions   Slight discharge, discharge with moistening of considerable areas around the eye. The findings were recorded until day 9.

Applicant's summary and conclusion

Interpretation of results:

moderately irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Executive summary:

Isophamchloride was investigated for irritant effects on the rabbit eye and associated membranes. The test substance was applied in a single dose (0.063 to 0.073g) into one conjunctiva sac each of three animals.

The primary irritation index was 26 and is classified as moderately irritant to the eye of the rabbit.

Systemic toxic effects were not detected.